Subjects will undergo two bronchoscopy procedures two months apart and will be treated with AeriSeal foam unilaterally, in two sub-segments during each bronchoscopy (4 segments treated in total).

Detailed Description:

The AeriSeal-STAGE trial will be a prospective, multicenter study that intends to evaluate the safety of a modified staged treatment algorithm with an escalation of dose using the AeriSeal System in the treatment of subjects with severe emphysema in a controlled trial design setting as compared to published data from prior studies. The trial is anticipated to enroll fifteen (15) study subjects with homogeneous, or upper lobe predominant heterogeneous emphysema, in three (3) centers in Europe.

Eligibility

Ages Eligible for Study:

40 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject is willing and able to provide informed consent and to participate in the study

Congestive heart failure within 6 months of Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction < 45% on echocardiogram

25) Subject has been diagnosed with diabetes mellitus 26) Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject i.e., alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02877459